CLINITEK ADVANTUS
Received Feb 5, 2026 · Event occurred Jan 6, 2026
Report 3002637618-2026-00005 · MDR key 24268152
Device
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SIEMENS REQUESTED MATERIALS TO BE RETURNED FOR FURTHER INVESTIGATION. THE CUSTOMER STATED THAT THE REAGENT WAS NO LONGER AVAILABLE AND THAT THE INSTRUMENT HAD BEEN SENT FOR SERVICING. SIEMENS HAS REQUESTED THE SERVICE REPORT. THE CAUSE OF THIS EVENT IS UNKNOWN.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSE NEGATIVE LEUKOCYTE RESULT ON ONE PATIENT COMPARED TO RETESTING OF THE SAME SAMPLE ON THE SAME INSTRUMENT AND MICROSCOPIC ANALYSIS. THE EXACT MICROSCOPIC RESULTS WERE NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER STATED THAT THEY PERFORMED MAINTENANCE AS REQUIRED AND RUNS QC DAILY AND IT WAS PASSING. THERE IS NO REPORT OF HARM DUE TO THIS EVENT.
Additional Manufacturer Narrative
SIEMENS HAS COMPLETED THE INVESTIGATION. THE RETURNED DEVICE WAS EVALUATED. TESTING WAS PERFORMED ON RETURNED DEVICE. THE DEVICE PASSED ALL FUNCTIONAL TESTS. REVIEW OF INTERNAL RECORDS DO NOT IDENTIFY ANY PRODUCTION ISSUES, DEVIATIONS, OR OTHER ESCALATIONS THAT WOULD BE RELATED TO THE CUSTOMER¿S REPORTED ISSUE. NO OTHER CUSTOMER COMPLAINTS WERE RECEIVED ON THE LOT IN QUESTION. THE CAUSE OF THE EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.